Application Procedure

Prior to IRB review, research involving nursing my require review and approval by the Nursing Research Committee.  Please contact the IRB for further direction and information regarding submission to this committee.

New Investigators and study staff must complete training in the protection of human research subjects prior to receiving IRB approval of a protocol.  Training information and materials may be obtained by contacting the IRB office or reading the Training of Investigators and Study Staff topic page.

The IRB instructions and application are available for download in Microsoft Word format or by contacting the IRB office. 

The IRB offers four different consent form templates for each category of research with the exception of retrospective record reviews.  Their use is recommended but not required. 

            Template 1: Interventional studies involving drug or devices

            Template 2:  Social or behavioral research studies

            Template 3:  Establishment of a research registry or database

            Template 4:   Case reports, case series, or prospective record review

Please note that approval may be delayed if elements of the application submission package are missing or incomplete.  An application submission package consists of the following:

• Application*:  Typewritten with all sections completed and signed by the Principal Investigator.  Saint Francis Hospital and Medical Center policy does not allow for students, residents, or trainees to act as Principal Investigators; these individuals will need to find a qualified member of the Medical, Dental, or Nursing staff to act as the Principal Investigator.  Please submit the original document plus 11 copies.

• Consent document:   If applicable, a document that is appropriate to the proposed research and is written in simple, non-technical language that can be easily understood by the prospective subjects.  Please submit one unstapled, paper or binder clipped copy plus 11 stapled copies.

• Sponsor sample/template consent:  If applicable, provide the sponsor sample/template consent document which was used to develop the final consent document.  Language and information revisions regarding risks, procedures, and other elements of consent need to be justified in writing.  Minimal clarification and simplification of language and information does not constitute the need to justify changes in writing.  Please submit two copies of the sample/template document.

• Waiver of consent:  If a waiver is requested, a typewritten Waiver of Individual Authorization for Disclosure of Protected Health Information Questionnaire with all sections completed and signed by the Principal Investigator must be submitted with the application.  Please submit the original document plus 11 copies.

• Protocol*:  If applicable, the document may be written in technical language which provides a complete description of the proposed research and procedures.  A protocol must be submitted for all a sponsored research studies or for any investigator initiated interventional research study.  Please submit two copies of the full protocol including any appendices.

If the sponsor has provided a sample/template protocol for use in developing the final site specific protocol, language and information revisions regarding risks and procedures (e.g. participation in only one arm of the study versus all arms) need to be justified in writing.  Minimal clarification and simplification of language and information does not constitute the need to justify changes in writing.  Please submit two copies of the sample/template document including any appendices.

• Investigator's Brochure: If applicable, the investigator's brochure, including data on previous animal and human experience associated with the investigational article, must be submitted with the application.  This applies to interventional research involving drug or device protocols.  Please submit two copies of the full document including any appendices.

• Assessment materials:  The IRB must review and approve all documents which the subject will encounter during study participation and/or any formal data collection forms which will be used in a study.  These documents include, but are not limited to questionnaires, interview/survey forms, experiment session outlines, instructional sheets, and focus group discussion outlines.  Please submit one unstapled, paper or binder clipped copy plus 11 stapled or binder clipped copies.

• Advertisement(s) for subject recruitment: If applicable, all advertisements used for subject recruitment need IRB approval prior to their use.  Guidelines for advertisements are included in the IRB application instructions.  Please submit 12 copies.

• Form 1571 and Form 1572:  If the study will be conducted by a sponsor under an investigational new drug (IND) or investigational device exemption (IDE), a FDA form 1571 and form 1572 for the principal investigator must be included with the application.  Please submit one copy of each document.

• Research Contract*:  If the study will be funded and conducted by a sponsor, a copy of the fully executable sponsor-investigator contract/agreement must be included with the application.  The contract must be submitted to the Department of Legal Services for review and approval prior to receiving IRB approval. Please submit one copy. 

• Curriculum vitae:  A CV or resume for each investigator listed on the application must be provided if a copy is not already on file with the IRB.  Investigators may submit a CV/resume with each new submission to ensure that the most current copy of the document is on file with the IRB.   Please submit one copy for each investigator listed.

• Financial Disclosure and Conflict of Interest form:  A Financial Disclosure and Conflict of Interest form for each investigator listed on the application must be completed.  Please note that section A is for individuals who do not have a conflict of financial interest to disclose; section B is for individuals who have a conflict or financial interest to disclose.  Section B must be completed if the investigator has involvement in the study design, implementation, and data collection.  Please submit one copy for each investigator listed.

• Unaffiliated Investigator Agreement (UIA): If applicable, an UIA for each investigator who is not affiliated with St. Francis Hospital and Medical Center must be completed and submitted with the application.  Affiliation with St. Francis Hospital and Medical Center includes members of the Medical, Dental or Nursing staff, Woodland Physicians and Asylum Hill Family Medicine Associates.  UIAs need to be submitted directly to the IRB office and not to the Signatory Official listed on the document.  Please submit one copy for each investigator listed to which this applies.

• Training documentation: All investigators and research staff must provide documentation of training in the protection of human research subjects if a copy is not already on file with the IRB.  Training information and materials may be obtained by contacting the IRB office or reading the Training of Investigators and Study Staff topic page.  Please submit one copy for each investigator listed.

*For studies which involve the use of investigational drugs:
Investigational drugs must be stored in the hospital Pharmacy unless the investigator ensures that storage, dispensing, accountability, and security comply with institutional policy and federal and state laws.  The Director of Pharmacy, or delegated pharmacy staff, must approve plans for control of investigational drugs maintained outside of the pharmacy.  Investigators who choose to store investigational drugs outside the Pharmacy will be subject to regular auditing by the Pharmacy. 

Drug costs, when applicable, and other Pharmacy expenses associated with the study will be charged to the investigator and must be properly allocated for in the research contract or study budget and reimbursed to the Pharmacy.   A department budget or special fund account will need to be provided to the Pharmacy from which the following fees will be drawn:

• Study initiation (one time fee)
• Randomization (per subject enrolled)
• Drug preparation and dispensing (per dose)
• Drug cost (for non-sponsored studies)
• Inventory and record keeping (monthly fee which includes quality assurance measures, monitor site visits, and drug storage)
• Study closure (one time fee which includes destruction of remaining drug, copying and archiving study related information)

Please note that even if the Pharmacy is not storing or dispensing study drugs study initiation fees will be charged to cover the costs of protocol review and to ensure that drugs not handled by the Pharmacy are in accordance with regulatory standards.

Please contact the Director of Pharmacy at (860) 714-7983 for further information.